Thompson
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Midline 57x83mm 1x3/16in Toe EUDAMEDThompson FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, reusable FDA UDI
- Device Name
- Midline 57x 83mm 1x3/16in Toe FDA UDI
- Model / Reference
- 6343 EUDAMEDFDA UDIThompson Retractor System EUDAMED
- Description
- Midline 57x 83mm 1x3/16in Toe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841536138672 EUDAMEDFDA UDI
- Basic UDI-DI
- 008415361TRMR EUDAMED
- Direct Marketing DI
- 00841536138672 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical retractor/retraction system blade, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Surgical retractor/retraction system blade, reusable
Thompson by Thompson Surgical Instruments — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Thompson Surgical Instruments
Sources (2)
- FDA UDI 193140ec-93bb-4b4c-9ef5-149d242dd8dd 34 fields · synced Jun 18, 2026
- EUDAMED 655608b9-0e62-4d90-ac60-4142d2d9d3e6 61 fields · synced Jun 18, 2026